(86 days)
No
The description focuses on mechanical compression and material properties, with no mention of AI/ML terms or functionalities.
Yes
The device is designed to prevent DVT by increasing venous blood flow, which is a therapeutic purpose.
No
The device is designed to prevent DVT by increasing venous blood flow, which is a therapeutic function, not a diagnostic one. It does not identify or diagnose a disease.
No
The device description clearly outlines physical components (sleeves made of PVC laminate, polyester foam) and their interaction with a pump (K010744), indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow." This is a therapeutic and preventative function performed directly on the patient's body.
- Device Description: The device is a mechanical compression system applied to the limbs. It works by physically compressing the limb to increase blood flow.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or conditions. This device operates externally on the patient's limb for a therapeutic/preventative purpose.
N/A
Intended Use / Indications for Use
The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.
Product codes
JOW
Device Description
The STS range of sleeves, are three chamber graduated, sequential compression sleeves, to be used in conjunction with the Huntleigh AC600 Flowtron Universal pump (K010744).
The STS range of compression sleeves consist of two sheets of PVC laminate materials welded together to form three chambers. On the proposed device, a single tube into the lower chamber inflates the complete sleeve. proposed devices and gradient inflation of the middle and upper chambers is achieved by a series of bleed channels between chambers and bleed orifices to atmosphere. On the predicate device, the material in contact with the patient's skin is non-woven fibre. The STS has a layer of polyester foam against the patient's skin, identical in composition to other approved Huntleigh sleeves. The systems have similar fault alarms, i.e. low pressure, blocked/kinked tubes, and system faults.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical, inflation performance testing was conducted. The sleeves are tested by fitting to a subject's limbs and the pressure/time cycle results compared. The sleeves are made from similar materials and compress a similar area of the patient's limb. The inflation sequence and pressures in each chamber are similar.
Key Metrics
Not Found
Predicate Device(s)
Kendall SCD Therapeutic System K890938
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
SEP 2 1 2001
Image /page/0/Picture/2 description: The image shows the logo for Huntleigh Healthcare. The logo consists of the word "Huntleigh" in a serif font, with the word "HEALTHCARE" in a smaller serif font directly below it. Above the text is a symbol that resembles a stylized building or structure, composed of several horizontal bars with a vertical gap in the center.
510(k) SUMMARY
STS Compression Sleeves
| Company | Huntleigh Healthcare Inc
40 Christopher Way
Eatontown
New Jersey |
|--------------------------|-------------------------------------------------------------------------------------------|
| Contact | Audrey Witko
Phone 732 578 9898
Fax 732 460 5809 |
| Summary Preparation Date | 19 June 2001 |
| Trade Name | STS20 Knee Length Size
STS30 Thigh Length Medium Size
STS40 Thigh Length Large Size |
| Common Name | Gradient, Sequential Compression Sleeves |
| Classification Name | Sleeve, Limb, Compression (JOW) |
| Predicate Device | Kendall SCD Therapeutic System K890938 |
Device Description
The STS range of sleeves, are three chamber graduated, sequential compression sleeves, to be used in conjunction with the Huntleigh AC600 Flowtron Universal pump (K010744)
Intended Use
The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.
Summary of Technological Characteristics
The STS range of compression sleeves consist of two sheets of PVC laminate materials welded together to form three chambers. The size and shape of these chambers are similar to the predicate device, as is the method of fitting to the patient's limb.
On the predicate device, separate tubes individually inflate the three chambers. On the proposed device, a single tube into the lower chamber inflates the complete sleeve. proposed devices and gradient inflation of the middle and upper chambers is achieved by a series of bleed channels between chambers and bleed orifices to atmosphere.
On the predicate device, the material in contact with the patient's skin is non-woven fibre. The STS has a layer of polyester foam against the patient's skin, identical in composition to other approved Huntleigh sleeves.
1
The systems have similar fault alarms, i.e. low pressure, blocked/kinked tubes, and system faults.
Determination of Substantial Equivalence
The determination of Substantial Equivalence is based on non-clinical, inflation performance testing. The sleeves are tested by fitting to a subject's limbs and the pressure/time cycle results compared.
Equivalence Testing Results
The sleeves are made from similar materials and compress a similar area of the patient's limb. The inflation sequence and pressures in each chamber are similar.
Therefore, we propose that the clinical treatment that the patient receives will be equivalent.
2
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human profiles facing to the right.
SEP 2 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Audrey Witko Huntleigh Healthcare, Inc. 40 Christopher Way Eatontown, NJ 07724
Re: K012008
Trade Name: STS Range Models STS20, STS30, and STS40 Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve, Limb, Compression Regulatory Class: Class II (two) Product Code: JOW Dated: June 27, 2001 Received: June 27, 2001
Dear Ms. Witko:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Audrey Witko
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
signature
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
STS Compression Sleeves
| Ver/3 - 4/24/96 | |
|---|---|
| Applicant: | Huntleigh Healthcare Inc. |
| 510(k) Number (if known): | Not known at present K012008 |
| Device Name: | STS |
| Indications For Use: | |
| The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow. |
Division of Cardiovascular & Respiratory Devices
510(k) Number K012006
(PLEASE DO NOT WRITE BELOW THIS LIME – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)